- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02764593
Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer
Safety Evaluations of Nivolumab (Anti-PD-1) Added To Chemotherapy (CRT) Platforms In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Palo Alto, California, Estados Unidos, 94304
- Stanford Cancer Institute
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Florida
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Orlando, Florida, Estados Unidos, 32806
- University of Florida Cancer Center at Orlando Health
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University/Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- UPMC - Shadyside Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042
- Inova Fairfax Hospital
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospital and Clinics
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Histologically or cytologically-confirmed diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx.
- Intermediate-risk group: Oropharynx cancer that is p16-positive by immunohistochemistry with smoking status > 10 Pack-years, stage T1-2N2b-N3 OR ≤ 10 pack-years, stage T4N0-N3 or T1-3N3.
High-risk group: Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer, stage T1-2N2a-N3 or T3-4-N0-3 based on the following diagnostic workup:
- Mandatory submission of H&E and p16 stained slides for central review of p16 staining is required for oropharyngeal patients and H&E stained slide block (or punch biopsy of paraffin block) for PD-L1 expression analysis for all patients
- History/physical examination within 28 days prior to registration
- Examination by Radiation Oncologist, Medical Oncologist, and Ear, Nose, Throat (ENT) or Head & Neck Surgeon within 28 days prior to registration
- Fiberoptic exam with laryngopharyngoscopy within 28 days prior to registration
- Diagnostic quality, cross sectional imaging of the thorax within 28 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable.
- Diagnostic quality CT or MRI of neck, with contrast, within 28 days prior to registration; a 18-F-FDG-PET/CT of the neck only is acceptable as a substitute if the CT is of diagnostic quality and with IV contrast.
- Age ≥ 18 years
- The trial is open to both genders
Exclusion Criteria:
- Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease.
- Patients with oral cavity cancer are excluded from participation if resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist.
- Carcinoma of the neck of unknown primary site origin (even if p16-positive).
- Absence of RECIST, v. 1.1 defined measurable disease.
- Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. Patients with RECIST, v. 1.1 evaluable remaining cancer either in the neck or primary site remain eligible.
- Simultaneous primary cancers or separate bilateral primary tumor sites.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy for the study cancer.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Patients with active autoimmune disease, with exceptions of vitiligo, type I diabetes mellitus, hypothyroidism and psoriasis.
- Use of systemic corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration, with exception of inhaled or topical steroids.
- Known immunosuppressive disease, for example HIV infection or history of bone marrow transplant or chronic lymphocytic leukemia (CLL).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Arm 1 (Nivolumab + Cisplatin)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
Cisplatin will be given weekly.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
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Anti-PD-1 targeted immunotherapy
Outros nomes:
Anti-cancer alkylating agent
Outros nomes:
High-precision radiotherapy
Outros nomes:
|
Experimental: Arm 2 (Nivolumab + High-dose Cisplatin)
Patients will receive Nivolumab via IV administration starting 14 days prior to IMRT, then Day 1 of IMRT and then every 21 days for 6 doses.
Cisplatin will be given every 21 days for 3 doses.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
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Anti-PD-1 targeted immunotherapy
Outros nomes:
Anti-cancer alkylating agent
Outros nomes:
High-precision radiotherapy
Outros nomes:
|
Experimental: Arm 3 (Nivolumab + Cetuximab)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
Cetuximab will be given for 7 doses.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
Outros nomes:
High-precision radiotherapy
Outros nomes:
Epidermal Growth Factor Receptor (EGFR) antagonist
Outros nomes:
|
Experimental: Arm 4 (Nivolumab + IMRT)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
Outros nomes:
High-precision radiotherapy
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Dose Limiting Toxicity (DLT)
Prazo: From the first dose of nivolumab to 28 days after the completion of radiation therapy.
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A nivolumab attributable, dose-limiting toxicity (DLT) will be defined as follows: 1) Any ≥ grade 3 adverse event (CTCAE, v. 4) that is related to nivolumab that does not resolve to grade 1 or less within 28 days; 2) A delay in radiotherapy of > 2 weeks due to toxicity related to nivolumab; 3) Inability to complete radiotherapy due to toxicity related to nivolumab; 4) Inability to receive an adequate dose (≥ 70%) of cisplatin (Arm 1 and 2) or cetuximab (Arm 3) due to toxicity definitely related to nivolumab. |
From the first dose of nivolumab to 28 days after the completion of radiation therapy.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maura Gillison, MD, PhD, RTOG Foundation
- Investigador principal: Robert Ferris, MD, PhD, RTOG Foundation
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias de Cabeça e Pescoço
- Neoplasias de Células Escamosas
- Carcinoma
- Carcinoma de Células Escamosas
- Carcinoma Espinocelular de Cabeça e Pescoço
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de Ponto de Verificação Imunológica
- Nivolumabe
- Cetuximabe
Outros números de identificação do estudo
- RTOG 3504
- RF 3504 (Outro identificador: RTOG Foundation)
- CA209-410 (Outro identificador: Bristol-Myers Squibb)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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